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Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome (FORTITUDE)

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ClinicalTrials.gov Identifier: NCT03899779
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE February 13, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date September 3, 2020
Actual Study Start Date  ICMJE July 8, 2019
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
Abdominal pain response rate after 12 weeks of treatment [ Time Frame: 12 weeks ]
A responder is defined as a patient who experiences at least a 30 percent decrease in the weekly average of worst daily abdominal pain (measured daily, on an 11 point NRS) compared to baseline weekly average in at least 50 percent of the weeks in which the treatment in given.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Degree of relief response rate after 12 weeks of treatment [ Time Frame: 12 weeks ]
    A responder is defined as a patient who experiences a weekly relief of 1 or 2 (on a 7 point NRS) in at least 50 percent of the weeks in which treatment is given.
  • Improvement of symptom severity [ Time Frame: 16 weeks ]
    determined by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) by 50 points or more [IBS-SSS, minimum score 0, maximum score 500]
  • Indirect costs [ Time Frame: 16 weeks and after 6 months and 1 year follow-up ]
    determined by Productivity Cost Questionnaire (PCQ) (savings from increased work productivity)
  • Direct costs [ Time Frame: 16 weeks and after 6 months and 1 year follow-up ]
    determined by Medical Consumption Questionnaire (MCQ) (savings from reduced medical resource use)
  • General Quality of life (by EQ-5D) [ Time Frame: 16 weeks and after 6 months and 1 year follow-up ]
    Determined by the Euro-Quality of Life - 5 domains (EQ-5D-5L) (change from baseline)
  • IBS related Quality of life (by IBS-QoL) [ Time Frame: 16 weeks and after 6 months and 1 year follow-up ]
    Determined by IBS Quality of Life (IBS-QoL) (change from baseline) [IBS-QoL, minimum score: 0, maximum score 100]
  • Use of over the counter medication and rescue medication [ Time Frame: 12 and 16 weeks ]
    As reported via digital diary (mobile phone application)
  • Number and severity of side effects [ Time Frame: 12 and 16 weeks ]
    As reported via digital diary (mobile phone application)
  • Expectation [ Time Frame: 16 weeks ]
    Response rates in relation to patient expectation prior to the start of treatment
  • Response rates in relation to comorbid anxiety [ Time Frame: 16 weeks and after 6 months and 1 year follow-up ]
    Assessed with the use of the Generalized Anxiety Disorder-7 (GAD-7). [GAD-7 minimum score: 0, maximum score: 21]
  • Response rates in relation to comorbid depression [ Time Frame: 16 weeks and after 6 months and 1 year follow-up ]
    Assessed with the use of the Patient Health Questionnaire-9 (PHQ-9). [PHQ-9 minimum score: 0, maximum score: 21]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome
Official Title  ICMJE Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome, According to a Non-inferiority Design. Three-armed Randomized Controlled Trial.
Brief Summary Psychological therapies are effective in reducing irritable bowel syndrome (IBS) symptom severity and increasing quality of life and are recommended for the management of IBS by guidelines. Evidence appears strongest for the efficacy of hypnotherapy as psychological treatment. However, therapist-led interventions are time consuming and relatively costly. Approaches based on e-health are cost saving and appear more attractive to patients as no visits to a therapist are necessary. Therefore, the investigators plan to conduct a multicentre randomised controlled trial to examine whether the effectiveness of online hypnotherapy is non-inferior compared to individual face-to-face hypnotherapy delivered by a therapist, according to current FDA guidelines. Online psychoeducation will be used as control condition. In addition, the investigators hypothesize that treatment with online hypnotherapy is a more cost-effective therapy than face-to-face hypnotherapy in IBS patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Other: Face-to-face hypnotherapy
    12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
  • Other: Online hypnotherapy
    12 weeks treatment with online hypnotherapy
  • Other: Online psychoeducation
    12 weeks treatment with online psychoeducation
Study Arms  ICMJE
  • Active Comparator: Face-to-face hypnotherapy
    12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
    Intervention: Other: Face-to-face hypnotherapy
  • Experimental: Online hypnotherapy
    12 weeks treatment with online hypnotherapy
    Intervention: Other: Online hypnotherapy
  • Active Comparator: Online psychoeducation
    12 weeks treatment with online psychoeducation
    Intervention: Other: Online psychoeducation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2019)
285
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Age 16-65 years
  • A diagnosis of IBS according to the Rome IV criteria
  • In the presence of alarm symptoms, such as rectal blood loss, weight loss, anemia, first onset of symptoms above 50 years of age, patients will be first referred for further investigation by their treating physician to exclude organic disorders, conform current Dutch guidelines for IBS.
  • Women in fertile age must use contraception or be postmenopausal for at least two years.

Exclusion criteria:

  • Insufficient command of the Dutch language
  • No access to internet
  • Evidence of current anxiety and/or depression disorder as defined by a score ≥10 on the GAD-7 and/or PHQ-9 questionnaire. In this case it is conceivable that the IBS symptoms are strongly related to psychopathology for which different treatment might be more appropriate.
  • History of ulcerative colitis, Crohn's disease, coeliac disease or significant liver disease
  • Major surgery to the lower gastrointestinal tract, such as partial or total colectomy, small bowel resection or partial or total gastrectomy
  • Past or present radiotherapy to the abdomen
  • Current pregnancy or lactation
  • Using of psychoactive medication in case there's no stable dose for at least 3 months prior to inclusion
  • Use of over-the-counter or prescription antidiarrheals, analgesics and laxatives (only be allowed as specific rescue medication)
  • Hypnotherapy treatment received in the last 3 months prior to inclusion
  • Using more than 20 units of alcohol per week
  • Using drugs of abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anke Snijkers, MD 0031433882952 fortitude-intmed@maastrichtuniversity.nl
Contact: Daniel Keszthelyi, MD, PhD daniel.keszthelyi@maastrichtuniversity.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03899779
Other Study ID Numbers  ICMJE NL67607.068.18
852001924 ( Other Grant/Funding Number: ZonMw )
METC18-037 ( Other Identifier: METC azM/UM )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE ZonMw: The Netherlands Organisation for Health Research and Development
Investigators  ICMJE
Principal Investigator: A.A.M. Masclee, Prof., MD Maastricht University Medical Center
PRS Account Maastricht University Medical Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP